FDA Orange Book
Generic for Urecholine
Urecholine contains bethanechol chloride. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Urecholine is bethanechol chloride. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA. Generics match 4 of the 5 Urecholine products the Orange Book lists.
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Urecholine products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 5MG/ML | Discontinued | None | 0 | None |
| tablet, oral | 10MG | Discontinued | None | 5 | AA |
| tablet, oral | 25MG | Discontinued | None | 5 | AA |
| tablet, oral | 50MG | Discontinued | None | 5 | AA |
| tablet, oral | 5MG | Discontinued | None | 4 | AA |
NDA 006536, held by TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic bethanechol chloride
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| UPSHER SMITH LABORATORIES LLC | 040634 | AA (A-rated, therapeutically equivalent) | June 1, 2005 | 10MG |
| UPSHER SMITH LABORATORIES LLC | 040635 | AA (A-rated, therapeutically equivalent) | June 1, 2005 | 25MG |
| UPSHER SMITH LABORATORIES LLC | 040636 | AA (A-rated, therapeutically equivalent) | June 1, 2005 | 50MG |
| UPSHER SMITH LABORATORIES LLC | 040633 | AA (A-rated, therapeutically equivalent) | June 1, 2005 | 5MG |
| CHARTWELL RX SCIENCES LLC | 040728 | AA (A-rated, therapeutically equivalent) | October 26, 2007 | 10MG, 25MG, 50MG, 5MG |
| AMNEAL PHARMACEUTICAL | 040855 | AA (A-rated, therapeutically equivalent) | November 21, 2007 | 10MG, 25MG, 50MG, 5MG |
| HERITAGE PHARMA LABS INC | 091256 | AA (A-rated, therapeutically equivalent) | May 4, 2010 | 10MG, 25MG, 50MG, 5MG |
| CHARTWELL RX SCIENCES LLC | 086262 | AA (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 10MG |
| CHARTWELL RX SCIENCES LLC | 086263 | AA (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 25MG |
| CHARTWELL RX SCIENCES LLC | 085882 | AA (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 50MG |
Questions
Is there a generic for Urecholine?
Yes. The generic name for Urecholine is bethanechol chloride. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA. Generics match 4 of the 5 Urecholine products the Orange Book lists.
What is the generic name for Urecholine?
The active ingredient in Urecholine is bethanechol chloride, per the FDA Orange Book.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.